Impact of the Coronavirus Disease 2019 (COVID-19) on Sperm Parameters

Sponsor
Fertilys (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04937608
Collaborator
Institut national de la recherche scientifique, Laval, Québec (Other)
60
1
20.5
2.9

Study Details

Study Description

Brief Summary

This study aims to better understand the effects of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, virus that causes the coronavirus disease 2019 (COVID-19), on male fertility.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Sperm analysis

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent will produce a sperm sample by masturbation. Patients will also complete a questionnaire relating to their state of health. Six month following the first sperm sample, patients will produce another sperm sample by masturbation. These sperm parameters will be compared with the ones from a sperm analysis performed less than 2 years before the SARS-CoV-2 infection.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Impact of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection on the Sperm Parameters of Infertile Men
Actual Study Start Date :
Aug 13, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

Arm Intervention/Treatment
COVID-19 group

men aged 18 to 45 who have been infected with SARS-CoV-2 in the past 6 months

Diagnostic Test: Sperm analysis
Routine sperm analysis including analysis of sperm concentration, motility, vitality and morphology. Sperm DNA integrity will also be assessed.

Control group

healthy men aged 18 to 45 with normal sperm parameters (WHO 2010 criteria) and who have never contracted COVID-19

Diagnostic Test: Sperm analysis
Routine sperm analysis including analysis of sperm concentration, motility, vitality and morphology. Sperm DNA integrity will also be assessed.

Outcome Measures

Primary Outcome Measures

  1. Changes in sperm parameters quality [Pre-infection, on the day of recruitment and six month later]

    Sperm concentration and motility will be assessed using computer-assisted sperm analysis (CASA). Sperm vitality and morphology will be evaluated using eosine-nigrosine and Romanowsky staining techniques, respectively. DNA fragmentation and sperm chromatin decondensation will be measured using the Terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) and aniline blue assays, respectively. These sperm parameters will be compared before and after SARS-CoV-2 infection and between the different time frames.

  2. Viral RNA in seminal plasma [Pre-infection, on the day of recruitment and six month later]

    The number of SARS-CoV-2 RNA copies and viral particles / mL of seminal plasma will be assessed

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Inclusion Criteria:
  • All men aged 18 to 45 having a sperm analysis done at the Fertilys fertility center in the last 2 years who have not contracted COVID-19, agreeing to participate in the study and having signed the consent form to participate in the study.

  • All men aged 18 to 45 having a sperm analysis done at the Fertilys fertility center in the last 2 years) who have contracted COVID-19 within the last 6 months, agreeing to participating in the study and having signed the consent form to participate in the study.

  • All men aged 18 to 45 years with a sperm concentration ≥ 15 million/mL, progressive motility ≥ 20% and a percentage of normal forms ≥ 2%.

Exclusion Criteria:
  • Men aged under 18 and over 45.

  • Men who cannot produce a sperm sample by antegrade ejaculation.

  • Men whose sperm concentration is <15 million/mL, progressive motility <20% and a percentage of normal forms <2%, determined following the production of a "reference" sperm sample, carried out before March 2020, i.e. before the COVID-19 pandemic.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fertilys Laval Quebec Canada H2P2L6

Sponsors and Collaborators

  • Fertilys
  • Institut national de la recherche scientifique, Laval, Québec

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fertilys
ClinicalTrials.gov Identifier:
NCT04937608
Other Study ID Numbers:
  • COVID-19 and sperm parameters
First Posted:
Jun 24, 2021
Last Update Posted:
Aug 24, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2021